Ischemic or Non-ischemic Cardiomyopathy Clinical Trial
Official title:
Cardiac Resynchronization Therapy (CRT) Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (ENHANCE CRT). A Prospective, Randomized, Postmarket, Pilot Study.
The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population. The left ventricular lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of care implant approach.
This is a prospective, pilot, multi-center, double-blinded, randomized post-market study to
assess the effect of left ventricular lead pacing location (guided via QLV measurement vs.
standard of care approach) in non-LBBB patients.
In the QLV arm the physician will:
1. Assess two branches of the coronary sinus - a non-traditional vessel (inclusive of the
anterior region) will be tested first and a traditional free lateral branch will be
tested second for LV lead placement.
2. Measure QLV for each of the four cathodes of the left ventricular lead in each branch.
3. Choose the vein branch and cathode with the longest QLV measurement and program a vector
based on that cathode.
In the standard of care group, the left ventricular lead placement will be carried out
according to the physician's standard of care implant approach.
The impact of the left ventricular lead position will be evaluated based on the patient's
response to CRT utilizing the Clinical Composite Score (cardiovascular death, heart failure
hospitalizations, New York Heart Association (NYHA) class, and Patient Global Assessment).
Authorized site personnel conducting the NYHA class assessment and Patient Global Assessment
will be blinded to the randomization assignment and lead implant technique.
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